Diclofenac plus B vitamins versus diclofenac monotherapy in lumbago: the DOLOR study
Mibielli MA, Geller M, Cohen JC
Published in Current Medical Research and Opinion
Methodology
Randomised, double-blind, parallel-group trial; twice-daily oral diclofenac with or without B1, B6 and B12 for up to 7 days; primary endpoint the number of patients with sufficient pain reduction (VAS under 20 mm plus satisfaction) at day 3.
Key Findings
372 adults with acute lumbago were randomised to twice-daily diclofenac 50 mg plus B vitamins (thiamine 50 mg, pyridoxine 50 mg, cyanocobalamin 1 mg; n = 187) or diclofenac 50 mg alone (n = 185) for up to 7 days. After 3 days, 46.5% of the combination group had achieved treatment success and left the study versus 29% on diclofenac alone (chi-square 12.06; p = 0.0005). The combination also gave greater pain reduction and better mobility and function, with a safety profile no different from diclofenac alone.
Conclusions
The combination of diclofenac with B vitamins was superior to diclofenac monotherapy in lumbago relief after 3 days of treatment. There were no differences in safety profile between the two study groups.
Limitations
Daily pain scores were only recorded until each patient withdrew, so follow-up is uneven; the trial was short (maximum 7 days), industry-relevant, and had no placebo-only arm.
Supplements Studied
The combination of diclofenac with B vitamins was superior to diclofenac monotherapy in lumbago relief after 3 days of treatment. There were no differences in safety profile between the two study groups.
Related Health Concerns
Study Details
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